Bandaging system

ABSTRACT

A bandaging system for use in the treatment of a patient with a venous leg ulcer comprising as an inner layer in the system a highly absorbent bandage which bandage comprises at least 5% by weight of a highly absorbent fibre and as a further layer in the system an elastic bandage.

[0001] This invention concerns a bandaging system and in particular abandaging system for use in the treatment of venous leg ulcers.

[0002] In the past it has been common to treat venous leg ulcers with afour layer system of bandaging, these layers comprising:

[0003] (i) an inner layer of absorbent orthopaedic wool for exudateabsorption and pressure redistribution;

[0004] (ii) a second layer of crepe bandage to apply low pressure to thelimb;

[0005] (iii) a third layer of elastic bandage to apply additionalpressure to the limb; and

[0006] (iv) a cohesive self-adherent bandage to secure the system inplace. Such a bandaging system is described in “The Function of MultipleLayer Compression Bandaging in the Management of Venous Ulcers”, DDIWright et al, SWM, 10, 109-10 1988.

[0007] While compression bandaging of the type described above canaccelerate healing of leg ulcers, the system has several disadvantages.These are that the application of four layers of bandaging is costly,time consuming, needs to be performed by trained and experienced staffand must be repeated at least weekly.

[0008] We have now found that it is possible to reduce the number oflayers of bandaging needed in a system by use of a highly absorbentbandage in combination with an elastic bandage.

[0009] Accordingly the present invention provides a bandaging system foruse in the treatment of a patient with a venous leg ulcer the systemcomprising as an inner layer in the system a highly absorbent bandagewhich bandage comprises at least 5% by weight of a highly absorbentfibre and as a further layer in the system an elastic bandage.

[0010] The use of a highly absorbent bandage in the bandaging systemgives the advantage that the number of layers can be reduced whilstmaintaining even pressure distribution and a seven day wear time by thepatient.

[0011] The bandaging system is preferably a compression bandaging systemwhich comprises an elastic bandage of the type disclosed in PCT/GB93/02469 to Brightwake Ltd or that marketed under the name SETOPRESS™ bySeton Healthcare Group of Oldham, England or that marketed under thename of TENSOPRESS™ by Smith and Nephew Ltd. We have found in apreferred embodiment of the invention that the bandaging system canconsist of two layers, one being the highly absorbent bandage and theother being an elastic compression bandage capable of generating apressure of 25-40 mmHg at the ankle and 15-20 mmHg at the calf.

[0012] The advantage of using a highly absorbent bandage in this manneris that the bandage is capable of absorbing and retaining exudate underthe conditions of sub-bandage pressure encountered in compressionbandaging. This ability to handle and retain exudate at sub-bandagepressure is not generally exhibited by bandages commonly used for ulcertreatment.

[0013] In the context of the present invention by highly absorbent ismeant that the fibre or bandage will absorb and retain exudate undertypical sub-bandage pressures, at least 25 g/g of water.

[0014] Suitable highly absorbent fibres for use in the bandage of thesystem of the present invention include OASIS™ fibre as disclosed in EP0269393 A, modified cellulose fibres as described in WO93/12275 toCourtaulds Plc or GB9301258 to Courtaulds Plc and alginate fibres asdescribed in WO 94/17227 to E. R. Squibb and Sons.

[0015] Preferably the highly absorbent bandage comprises at least 5% ofhighly absorbent fibre the balance of the bandage comprising cotton orviscose of ordinary absorbency. More preferably the bandage comprisesbetween 50% and 50% of highly absorbent fibre, more preferably 10% to15%.

[0016] Preferably the highly absorbent bandage comprises up to 10% of abicomponent fibre for example DANAKLON ES-C-PHIL™ a polyolefinbicomponent fibre ex Danaklon of Varde, Denmark.

[0017] The invention will now be illustrated by the following Examples.

EXAMPLE 1

[0018] A highly absorbent bandage as used in the bandaging systemaccording to the invention was made by preblending three componentfibres Oasis™, DANAKLON ES-C-PHIL™ and viscose in the requiredpercentages and then carding to form a batt. The batt was cross-laid tothe desired thickness before passing through a needle loom where thebatt was needled to impart structural integrity. The resultant web washeat treated in a tunnel oven to thermally bond the fabric. Theresultant stock was slit and cut to the required size for bandages.

EXAMPLE 2

[0019] The effect of pressure on the fluid uptake and fluid retentioncapabilities of a highly absorbent bandage as used in the bandagingsystem of the invention were compared to those of commercially availableorthopaedic wadding (an example of which is Velband which is commonlyused as layer one in a four layer bandaging system) in the followingway.

[0020] The fluid uptake of samples of wadding size 5 cm×5 cm wasmeasured by immersing the wadding in water for 30 minutes at 37° C. Thefluid uptake of the samples was calculated in terms of weight uptake persample weight (g/g) and weight uptake per unit area (g/cm²).

[0021] The fluid retention of the samples was measured by placing 100cm² samples on a stainless steel tray and immersing them in water at 20°C. for 10 seconds and allowing them to drain for 30 seconds. A 2kgweight was applied over the total area for 30 seconds and the fluiduptake of the samples calculated in units of weight uptake per sampleweight (g/g) and weight uptake per unit area (g/cm²). The results arepresented in the following tables in which:

[0022] Bandage 101 is a bandage comprising a mix of 90% viscose and 10%Danaklon as made by the method described in Example 1 except that thehighly absorbent fibre was omitted.

[0023] Bandage 102 is a bandage as used in the system according to theinvention comprising a mix of 78% viscose, 12% Oasis and 10% Danaklon asmade by the method described in Example 1.

[0024] Cellona™, Lantor Synthetics™, Soffban™, Softexe™, Velband™ andWebril™ are commercially available orthopaedic wadding materials fromvarious manufacturers. Velband™is commonly used as the inner layer inthe four layer bandaging system of the prior art referred to above.

[0025] CoV is the Coefficient of Variation and is a measure of thedegree of variation in the results for a particular bandage. FluidUptake (g) Fluid Uptake (g/cm2) Fluid Uptake (g/g) Bandage Mean SD CoVMean SD CoV Mean SD CoV Pressure = 0 mmHg, Test Fluid = Water Bandage101 3.755 0.200 5.334 0.150 0.008 5.334 18.093 1.242 6.865 Bandage 1025.941 0.566 9.524 0.238 0.023 9.524 29.605 1.114 3.763 Cellona 5.4090.244 4.519 0.216 0.010 4.519 24.313 0.779 3.203 Lantor Synthetic 5.5710.517 9.280 0.223 0.021 9.280 23.090 1.227 5.315 Soffban 4.504 0.4038.949 0.180 0.016 8.949 22.809 2.001 8.772 Softexe 5.886 0.752 12.7820.235 0.030 12.782 29.138 2.519 8.647 Velband 4.482 0.293 6.532 0.1790.012 6.532 15.710 0.975 6.206 Webril 3.490 0.135 3.863 0.140 0.0053.863 15.215 0.468 3.076 Pressure = 15 mmHg, Test Fluid = Water Bandage101 13.384 2.074 15.492 0.134 0.021 15.492 15.560 1.125 7.231 Bandage102 27.090 0.861 3.179 0.278 0.009 3.179 30.422 1.301 4.275 Cellona18.638 1.049 5.630 0.186 0.010 5.630 20.891 1.552 7.427 Lantor Synthetic20.448 0.460 2.289 0.201 0.005 2.289 22.762 0.796 3.495 Soffban 15.1301.649 10.901 0.151 0.016 10.901 17.997 1.092 6.070 Softexe 19.258 0.7904.101 0.193 0.008 4.101 21.786 1.022 4.692 Velband 18.067 0.318 1.7570.181 0.003 1.757 14.610 0.134 0.917 Webril 14.602 0.218 1.733 0.1260.002 1.733 13.009 0.329 2.526

[0026] These results show that a highly absorbent bandage suitable foruse in a bandaging system according to the invention has a greater fluidabsorbtion and retention capability under pressure than conventionalorthopaedic wadding. The improved fluid handling properties of thehighly absorbent bandage when used in a bandaging system according tothe invention enables the number of layers to be reduced whilemaintaining a 7 day wear time for the user.

[0027] From the results this is clearly seen in the fluid uptake figurespresented as g/g. These figures are a more reliable guide than eitherthe fluid uptake g or fluid uptake g/cm² figures as these do not allowfor variations in sample thickness. For example the highly absorbentbandage for use in the system according to the invention (Bandage 102)has a fluid uptake at 0 mmHg of 29.605 g/g. At 15 mmHg this increases to30.422 g/g. The closest conventional bandage in terms of results isSoftexe™ which has a fluid uptake at 0 mmHg of 29.138 g/g . At 15 mmHgthis decreases to 21.786 g/g. All of the other orthopaedic waddings,including Velband™, show a decrease in fluid retention under pressure.

EXAMPLE 3

[0028] In use the bandaging system is applied to the leg of a patientwith a leg ulcer firstly by winding the leg with an even layer of thehighly absorbent bandage and secondly by winding the leg with an elasticbandage applied over the highly absorbent bandage to generate sufficientsub-bandage pressure. This elastic bandage is preferably of the typedisclosed in PCT/GB 93/02469 to Brightwake Ltd or that marketed underthe name SETOPRESS™ by Seton Healthcare Group of Oldham, England or thatmarketed under the name of TENSOPRESS™ by Smith and Nephew Ltd. In apreferred embodiment the bandaging system comprises a dressing appliedto and in contact with the wound such as an occlusive hydrocolloiddressing such as GRANUFLEX™ or a fibrous dressing such as KALTOSTAT™.

1-10 (Canceled)
 11. A method of treating a leg ulcer comprising:applying a highly absorbent bandage which comprises at least 5% byweight of a highly absorbent fibre and up to 10% by weight of abicomponent fibre to cover (i) the ulcer or (ii) the ulcer covered by anocclusive hydrocolloid dressing; and applying as a second layer, anelastic bandage adapted to apply pressure to the highly absorbentbandage covering the ulcer.
 12. The method as claimed in claim 11,wherein said bandaging system is applied: (a) by winding the leg with aneven layer of the highly absorbent bandage; and (b) by winding the legwith the elastic bandage over the highly absorbent bandage.
 13. Themethod of claim 11, wherein the highly absorbent bandage is applied tocover the ulcer.
 14. The method of claim 13, wherein the highlyabsorbent bandage is adapted to absorb and retain at least 25 g waterper g highly absorbent bandage.
 15. The method of claim 13, wherein thehighly absorbent bandage comprises between 5% and 50% by weight of ahighly absorbent fibre.
 16. The method of claim 13, wherein the highlyabsorbent bandage comprises between 10% and 15% by weight of a highlyabsorbent fibre.
 17. The method of claim 11, wherein the highlyabsorbent bandage is applied to cover the ulcer covered by an occlusivehydrocolloid dressing.
 18. The method of claim 17, wherein the highlyabsorbent bandage is adapted to absorb and retain at least 25 g waterper g bandage.
 19. The method of claim 17, wherein the highly absorbentbandage comprises between 5% and 50% by weight of a highly absorbentfibre.
 20. The method of claim 17, wherein the highly absorbent bandagecomprises between 10% and 15% by weight of a highly absorbent fibre. 21.The method of claim 11, wherein the ulcer is located at or adjacent tothe ankle and the second bandage is wrapped around the ankle with apressure of 24 to 40 mm Hg.
 22. The method of claim 11, wherein theulcer is located at or adjacent to the calf and the second bandage iswrapped around the calf with a pressure of 15 to 20 mm Hg.